Prosthetic repair fabric

ABSTRACT

An implantable prosthesis is provided for repairing or augmenting anatomical weaknesses or defects, and is particularly suitable for the repair of soft tissue and muscle wall openings. The prosthesis includes a repair fabric with a generally triangular-shaped body and two tails extending outward from the base of the triangular body. The tails may be rounded to provide the repair fabric with a generally heart-shaped configuration. An opening is provided along the base of the body and between the two tails for receiving a tube-like structure, such as the esophagus. The prosthesis may include a layer of fabric that is constructed and arranged to allow tissue ingrowth and is susceptible to erosion into and the formation of adhesions with tissue and organs. One or more regions of the prosthesis may be configured to inhibit erosion into and/or the formation of adhesions with tissue and organs. The prosthesis may include an edge barrier that is attached to the tails and overlies a portion of the opening. A portion of the edge barrier may be folded into the opening to isolate the tube-like structure from an edge of the opening.

FIELD OF THE INVENTION

The present invention relates to an implantable prosthesis, and moreparticularly to a prosthetic repair fabric for use in soft tissue repairand reconstruction.

DISCUSSION OF RELATED ART

Various prosthetic repair materials have been proposed to repair andreinforce anatomical defects, such as tissue and muscle wall hernias.For example, a hiatal hernia occurs when a natural opening, or “hiatus,”in the diaphragm through which the esophagus extends, becomes enlarged,allowing the stomach to pass through the hiatus into the thoraciccavity.

Representative surgical treatments for a hiatal hernia may include acruroplasty, which involves tightening the crura of the diaphragm aroundthe esophagus to reduce the size of the hiatal hernia. It has also beenknown to use a prosthetic repair fabric in the surgical treatment of ahiatal hernia. Typically, a sheet of surgical mesh fabric, such as BARDMESH, commercially available in rectangular stock sheets, was customfashioned by a surgeon into a shape suitable for a particular patient'shiatal repair, such as a rectangular or oval shape. Typically, thesurgeon placed the mesh implant over the hiatal hernia.

It is one object of certain embodiments of the present invention toprovide a preformed prosthesis for the repair of a hiatal hernia.

It is another object of certain embodiments of the present invention toprovide a prosthesis for the repair of tissue defects, such as a hiatalhernia, that reduces the incidence of postoperative adhesions to and orerosion of tissue and organs, such as the esophagus, stomach and/orother surrounding viscera.

SUMMARY OF THE INVENTION

In one illustrative embodiment of the invention, an implantableprosthesis is provided for repairing a tissue or muscle wall defect inthe vicinity of a tube-like structure. The implantable prosthesiscomprises a repair fabric of implantable, biologically compatiblematerial. The repair fabric has an opening that is adapted to receivethe tube-like structure. The repair fabric includes a body portion andfirst and second tails extending away from the body portion. The bodyportion is configured in a generally triangular shape with a base havingfirst and second segments. The first tail extends from the first segmentof the base and the second tail extends from the second segment of thebase. The opening is located along the base between the first and secondtails.

In another illustrative embodiment of the invention, an implantableprosthesis is provided for repairing a tissue or muscle wall defect inthe vicinity of a tube-like structure. The implantable prosthesiscomprises a repair fabric of implantable, biologically compatiblematerial. The repair fabric has a generally heart shaped outer peripherywith an opening along a portion of the outer periphery that is adaptedto receive the tube-like structure.

In a further illustrative embodiment of the invention, a prostheticrepair fabric is provided for repairing a tissue or muscle wall defectin the vicinity of a tube-like structure. The prosthetic repair fabriccomprises a layer of fabric that is susceptible to the formation ofadhesions with and erosion into tissue and organs, and an edge barrierthat is adapted to inhibit the formation of adhesions with an edge ofthe fabric. The layer of fabric has an opening that is adapted toreceive the tube-like structure. The repair fabric includes a bodyportion and first and second tails extending away from the body portionwith the opening being located along the edge of the fabric between thefirst and second tails. The edge barrier is attached to the first tailat a first attachment point and to the second tail a second attachmentpoint. The first and second attachment points are aligned with eachother across a segment of the opening. A portion of the edge barrieroverlies a portion of the opening and extends between the first andsecond attachment points.

Other objects and features of the present invention will become apparentfrom the following detailed description when taken in connection withthe accompanying drawings. It is to be understood that the drawings aredesigned for the purpose of illustration only and are not intended as adefinition of the limits of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and other objects and advantages of the invention will beappreciated more fully from the following drawings, wherein likereference characters designate like features, in which:

FIG. 1 is a top plan view of a prosthetic repair fabric in accordancewith an illustrative embodiment of the present invention;

FIG. 2 is a bottom plan view of the prosthetic repair fabric of FIG. 1;

FIG. 3 is a cross-sectional view of the prosthetic repair fabric of FIG.1 taken along section line 3—3;

FIG. 4 is a top plan view of a prosthetic repair fabric in accordancewith another illustrative embodiment of the present invention;

FIG. 5 is a bottom plan view of the prosthetic repair fabric of FIG. 4;

FIG. 6 is a cross-section view of the prosthetic repair fabric of FIG. 4taken along section line 6—6;

FIG. 7 is a cross-sectional view of the prosthetic repair fabric similarto FIG. 6 before inversion of the prosthesis;

FIGS. 8–10 are schematic views of a manufacturing process forfabricating the prosthetic repair fabric of FIG. 4;

FIG. 11 is a partial top plan view of the prosthetic repair fabric ofFIG. 4 with the edge barrier partially collapsed along a first foldline;

FIG. 12 is a cross-sectional view of the prosthetic repair fabric ofFIG. 11 taken along section line 12—12;

FIG. 13 is a partial top plan view of the prosthetic repair fabric ofFIG. 4 with the edge barrier collapsed along a second fold line;

FIG. 14 is a cross-sectional view of the prosthetic repair fabric ofFIG. 13 taken along section line 14—14;

FIG. 15 is a partial top plan view of a prosthetic repair fabric inaccordance with another illustrative embodiment of the invention;

FIG. 16 is a partial top plan view of a prosthetic repair fabric inaccordance with a further illustrative embodiment of the invention;

FIG. 17 is a top plan view of a prosthetic repair fabric in accordancewith another illustrative embodiment of the present invention;

FIG. 18 is a bottom plan view of the prosthetic repair fabric of FIG.17;

FIG. 19 is a cross-sectional view of the prosthetic repair fabric ofFIG. 17 taken along section line 19—19;

FIG. 20 is a schematic view illustrating the cushioning effect of theerosion resistant edge of the prosthetic repair fabric of FIG. 17 whenengaged by the esophagus;

FIG. 21 is another schematic view illustrating the cushioning effect ofthe erosion resistant edge of the prosthetic repair fabric of FIG. 17when engaged by the esophagus;

FIG. 22 is a cross-sectional view similar to FIG. 19 of a prostheticrepair fabric in accordance with a further illustrative embodiment ofthe invention;

FIG. 23 is a top plan view of a repair fabric for fabricating animplantable prosthesis in accordance with another illustrativeembodiment of the present invention;

FIG. 24 is a top plan view of the implantable prosthesis formed byfolding the repair fabric of FIG. 23;

FIG. 25 is a cross-sectional view of the implantable prosthesis of FIG.24 taken along section line 25—25; and

FIG. 26 is a schematic view illustrating the prosthetic repair fabric ofFIG. 17 implanted in the abdominal cavity proximate to the esophagus.

DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

The invention is directed to an implantable prosthesis for repairing oraugmenting anatomical weaknesses or defects, and is particularlysuitable for the repair of soft tissue and muscle wall openings. Forease of understanding, and without limiting the scope of the invention,the prosthesis to which this patent is addressed is described belowparticularly in connection with a hiatal hernia repair. It should beunderstood, however, that the prosthesis is not so limited and may beemployed in other anatomical procedures, as would be apparent to one ofskill in the art. For example, the prosthesis may be used where atube-like structure or other projection extends from or passes throughan opening in a tissue muscle or organ wall requiring repair and/oraugmentation.

The prosthesis may be configured to reduce the incidence ofpost-operative erosion into adjacent tissue or organs, such as theesophagus or other cord-like structure, that may come into contact withthe prosthesis. Tissue and organs may be particularly susceptible toerosion or abrasion by the edge of a prosthetic repair fabric that ispositioned proximate to tissue and organs which lie transverse to theplane of the prosthetic fabric material, particularly in dynamicenvironments, such as the diaphragm. Thus, the prosthesis may beprovided with one or more erosion-resistant edges that act to buffer orotherwise isolate the edge of the repair fabric so as to reduce theincidence of erosion into adjacent tissue or organs.

A prosthesis with erosion resistant characteristics may be particularlysuitable in the repair of a hiatal hernia. The esophagus presents aprojecting structure proximate and generally perpendicular to the planeof the defect in the diaphragm. The diaphragm moves to assist inbreathing with sudden and extreme movement occurring in the case ofcoughing or sneezing, while the esophagus moves to assist in swallowingand regurgitating. This very dynamic environment of the esophagus anddiaphragm may increase potential erosion of the esophagus by aprosthesis implanted to repair the defect.

Erosion into adjacent tissues and organs may be affected by variousfactors and characteristics of the prosthetic repair fabric. Forexample, a more deformable prosthetic material may be less likely toerode into adjacent tissue and organs than a stiffer material.Similarly, a smoother or less abrasive material may be desirable toreduce erosion. The surface area of an edge presented to adjacent tissueand organs may be another factor, such that a broader edge may helpdistribute forces over a larger surface area to reduce erosion of tissueand organs. The edge of the repair fabric may be provided with a degreeof resiliency or spring-like action that creates a cushion or bumpereffect between the repair fabric and adjacent tissue and organs. Thus,the prosthesis may be configured with any one or combination of two ormore of these or other characteristics or features as would be apparentto one of skill in the art to reduce or inhibit erosion of tissue ororgans.

In some situations, adhesions to the implant may be undesirable sincethe prosthesis may work its way deep into or even through the tissueand/or the tissue may adhere to the prosthesis and be repetitively tornaway with body and muscle movements. Such adhesions and/or resultingscar tissue around the circumference of a cord-like structure, such asthe esophagus or other tube-like projection, may lead to strangulationof the structure.

While embodiments discussed below include an implant having one or moreportions that are tissue infiltratable, the invention is not so limitedand also contemplates a prosthesis that is not arranged for tissueingrowth. Still further embodiments include implants where tissueinfiltratable or otherwise erosion and/or adhesion sensitive portionsare rendered resistant to erosion and/or adhesion formation. In certainembodiments, some or all portions of the implant may be arranged fortissue ingrowth, while in other embodiments some or all portions of theimplant may be arranged to resist tissue ingrowth or otherwise to resisterosion and/or the formation of adhesions to and strangulation ofneighboring tissue or organs. The location of tissue ingrowth sectionsand barrier sections may vary along an edge of the implant, a surface ofthe implant, and/or sections of a body portion of the implant, asdiscussed below.

An implant according to the present invention, in connection with ahiatal repair, may include a body portion constructed and arranged tocover the enlarged or weakened portion of the hiatus, or the operativesutures used in repairing the hernia, such as are placed in acruroplasty. Some or all of the body portion may be tissueinfiltratable, may be impervious to tissue ingrowth or otherwiseresistant to erosion, or may include a combination of tissueinfiltratable and erosion resistant regions. In some embodiments, theprosthesis may be arranged to reduce the incidence of erosion and/or theformation of post-operative adhesions or strangulation of the cordstructure. The implant may be formed of a single or of multiple layersof prosthetic repair material, and the number of layers of prostheticmaterial may vary in different portions of the implant.

The implant may have a complete or partial opening that is adapted toreceive the esophagus or other cord-like structure. The opening may beformed along any one, or a combination, of the sides of the implant ormay be provided within and through the body portion. For the purposes ofthis patent specification, as well as any claims related thereto, thefeature of an “opening” adapted to receive the esophagus or tube-likestructure shall include a complete opening that is configured tocompletely surround the esophagus, and a partial opening that isconfigured to only partially surround the esophagus, even though thequalifier of “complete” or “partial” is not used. The opening may have around shape or any other shape that is constructed and arranged toposition the implant about the esophagus.

For the repair of a hiatal hernia, the prosthesis may include agenerally triangular-shaped body with a pair of tails extending from thebase of the body opposite its vertex. An opening for the receiving theesophagus may be formed between the base and the pair of tails. Moreparticularly, the implant may have a generally heart or arrowheadconfiguration that conforms to the shape of the crura. For otherapplications, the implant may have a circular shape, an ovoid or an eggshape, a C-shape, a bow tie shape, a butterfly shape, a rectangularshape, an arc shape, and other shapes as would be apparent to one ofskill in the art. The implant may be defined by an anterior end, aposterior end, a medial side and a lateral side. The sides and ends maybe of the same or of differing length and/or shape. Any of the sides andends may include a single straight edge, a curved edge, an edge formedof diverging or converging segments, and other shapes as would beapparent to one of skill in the art. The implant, viewed end-to-end orside-to-side may be symmetrically shaped or asymmetrically shaped.

The implant may be elongated in the anterior-posterior direction, in themedial-lateral direction or in a combination of the anterior-posteriorand medial-lateral directions. An implant having substantially the samelength in all directions also is contemplated. The implant may bepreshaped or may be custom shaped by the surgeon prior to or during thesurgical procedure. Similarly, the implant may be pre-arranged with aslit and keyhole opening, or one or both of these features may be leftto the surgeon to form.

The implant may, in an unstressed or natural state, such as prior toimplantation, have a generally flat or planar shape, or may be arrangedwith a concave and/or convex shape on one or more surfaces, or mayinclude a more complex three dimensional shape. A cord or other membermay be threaded through the implant and then manipulated, such as bydrawing ends of the cord extending outside of the implant, to transformthe prosthesis into a desired shape. The implant may be provided withshape influencing members, such as thin strips of metal, polymer, andthe like, that may be engaged to, or otherwise in contact with, theimplant and naturally or upon application of a force (e.g., heat) causethe prosthesis to form a predetermined shape.

The implant may be sufficiently flexible to allow a surgeon tomanipulate the fabric to conform to the surgical site and ease deliveryduring a laparoscopic procedure, or may have a stiffer arrangement thatlimits compression and/or expansion of the repair device. In certainembodiments, the implant may be collapsible, such as by folding,rolling, or otherwise, into a slender configuration that may bedelivered through a narrow lumen of a laparoscopic cannula or trocar.The flexibility of the implant is influenced by many factors includingthe materials from which the implant is constructed, any shapeinfluencing members, treatments applied to the material of the implant,and the amount of stitching or other attachment features in the body ofthe implant.

Certain portions of the implant may include a barrier which may beformed, for example and without limiting the invention, by applying abarrier material to selective regions of the prosthesis, by renderingselected porous regions of the implant less porous and, preferably,impervious to tissue infiltration, and by other arrangements as would beapparent to one of skill in the art. The barrier may be arranged toisolate the esophagus, and/or the abdominal viscera, from selectedportions of the implant that are abrasive or tissue infiltratable,reducing the incidence of esophageal, stomach, liver, and intestinetrauma associated with erosion, adhesion, constriction and the like.

As an example, and without limiting the inventive arrangementscontemplated for isolating the esophagus and viscera from variouspotential points of erosion and/or adhesion to the implant, the openingedge may be arranged with an opening edge barrier so that the openingedge is isolated from the portion of the esophagus passing through theopening. The margin areas surrounding the opening on the first, ordiaphragm facing, surface of the implant also may be isolated by an edgebarrier, limiting the prospects of contact between the segment of theesophagus extending through and adjacent the opening and the margins ofthe opening. Some or all of the second surface of the prosthesis, thatis the surface which will face the viscera, may include a surfacebarrier. The surface barrier may be arranged to cover substantially theentire second surface. A further outer edge barrier may be arranged atthe outer edge of the prosthesis to prevent adhesions with the cavityviscera by the outer periphery of the prosthesis. The outer edge barriermay also be configured or extended to isolate the margin of the firstsurface extending adjacent the outer edge of the layer of fabric. Theshape and dimension of the various barrier portions may be modified aswould be apparent to one of skill in the art, and the invention is notlimited to the particular configuration of the barrier sectionsillustrated in the figures.

FIGS. 1–3 illustrate one embodiment of a prosthetic repair fabric forrepairing soft tissue and muscle wall defects, particularly defectslocated proximate a tube-like structure, such as the esophagus or otherprojection, extending from or passing through an opening in a tissue,muscle or organ wall. The prosthetic repair fabric may be configured topromote enhanced tissue ingrowth while limiting the incidence ofpost-operative operative erosion into the surrounding tissue and organs.

The prosthesis 20 is configured to cover the enlarged or weakenedportion of the defect or the operative sutures repairing the defect. Theprosthesis has a first surface 26 for facing the defect region, such asthe diaphragm and a second surface 28 for facing the viscera. Theprosthesis may include a tissue infiltratable fabric 22. One or moreregions of the prosthesis may be configured as erosion resistant tolimit the incidence of postoperative erosion of selected regions of thefabric into adjacent tissue and organs, such as the esophagus or othercord-like structure.

In the illustrative embodiment, the prosthesis 20 includes a triangularbody portion 134 having a base 136 and first and second sides 138, 140that converge toward each other from the base to a vertex 146 locatedopposite the base. First and second tails 142, 144 extend away from thebody portion at first and second segments of the base, respectively. Asshown, the tails 142, 144 may have a rounded configuration that formlobes extending from the base of the body. In this regard, theprosthesis 20 has a generally heart shape configuration thatapproximates the shape of the crura.

To distribute tension forces generated on the prosthesis afterattachment of the prosthesis to the crura for a hiatal hernia repair,the first and second sides 138, 140 intersecting at the vertex 146 andthe tails 142, 144 may be configured to follow the shape of theunderlying crura. In this regard, the sides and tails are configured soas to distribute forces along the existing lines of tension within thecrura and diaphragm.

To avoid prolonged contact with the esophagus adjacent the hiatalhernia, the prosthesis 20 provides an opening 30 that is adapted to bepositioned proximate the esophagus. The opening 30, at the peripheraledge 32 of the prosthesis, is limited by the base of the body portionand the tails 142, 144 on either side.

In some instances, to repair soft tissue and muscle wall defects,particularly hiatal hernias, the prosthesis 20 may be formed of amaterial which promotes issue ingrowth. In one illustrative embodiment,the body portion 134 and the tails 142, 144 include a tissueinfiltratable fabric 22 which has a plurality of interstices or openingswhich allow sufficient tissue ingrowth to secure the prosthesis to hosttissue after implantation.

One or more selected regions of the prosthesis 20 may be renderedadhesion resistant to limit the incidence of postoperative tissueadhesion between the prosthesis and adjacent tissue and organs. Forexample, and without limiting the inventive arrangements contemplatedfor isolating the fabric from various points of adhesion, the prosthesismay include any one or combination of a surface barrier on one or bothsides of the fabric, an edge barrier along one or more edges of thefabric, and/or a margin barrier located proximate to one or more edgesof the fabric. The shape and dimensions of the various barrier portionsmay be modified as would be apparent to one of skill in the art, and theinvention is not limited to the particular configuration of the barriersections illustrated in the Figures.

The adhesion resistant regions may be formed, for example and withoutlimiting the invention, by applying a barrier material to selectiveregions of the prosthesis, by rendering selective porous regions of theimplant less porous and, preferably, impervious to tissue infiltration,and by other arrangements as would be apparent to one of skill in theart. The adhesion resistant barrier may be arranged to isolate theesophagus and/or the abdominal viscera from selected portions of theimplant that are tissue infiltratable, reducing the incidence of postoperative tissue adhesions.

In the illustrative embodiment shown in FIGS. 1–3, the prosthesisincludes a surface barrier 118 that is arranged to cover substantiallythe entire second surface 28 (viscera facing surface) of the fabric 22.In this manner, the surface barrier inhibits the formation of adhesionsbetween the fabric and the cavity viscera located opposite the defectsite. In one embodiment, the surface barrier 118 includes a sheet ofadhesion resistant material that is attached to the fabric.

The prosthesis also includes an edge barrier 114 that extends around atleast a portion of the outer peripheral edge of the fabric to reduce theincidence of adhesions between adjacent tissue and organs and selectedportions of the fabric edge. In the illustrative embodiment, the edgebarrier extends about the entire outer periphery of the prosthesis. Itis to be understood, however, that the edge barrier 114 may be providedon one or more selected portions of the prosthesis.

The edge barrier 114 may be formed by rendering a peripheral segment ofthe fabric 22 adhesion resistant. In one embodiment, the edge barrier isformed by melting and resolidifying or otherwise heat sealing the outerperiphery of the fabric. It is to be understood, however, that the edgebarrier may be formed by any suitable arrangement apparent to one ofskill in the art. For example, a barrier material may be used to coverthe fabric periphery or otherwise render the fabric adhesion resistantalong the periphery. Examples of suitable edge barriers are described inU.S. application Ser. No. 09/661,623, assigned to C. R. Bard, which isincorporated herein by reference.

A margin barrier is also provided to isolate a marginal portion of thefabric proximate the outer peripheral edge of the prosthesis. In theillustrative embodiment, the margin barrier 116 extends inwardly fromthe outer edge along the first surface 26 of the fabric layer 22 tolimit the likelihood of adhesion formation to the prosthesis were theouter edge 32 to fold back during placement or otherwise be exposed totissue and organs post procedure. In one embodiment, the margin barrieris formed by melting and resolidifying the outer marginal portion of thefabric. However, any suitable isolation arrangement may be employed aswould be apparent to one of skill, including the various barrierarrangements described above.

It may be desirable to render the prosthesis erosion resistant to limitthe incidence of postoperative erosion of tissue, muscle or organs bythe prosthesis. Accordingly, the prosthesis may include one or morebarriers that are configured and arranged to isolate the tissueinfiltratable fabric so as to inhibit undesirable erosion. Examples ofsuitable erosion and/or adhesion resistant edge barriers are describedU.S. application entitled “Prosthetic Repair Fabric with ErosionResistant Edge”, filed of even date herewith, assigned to C. R. Bard,which is incorporated herein by reference.

The prosthesis may be rendered erosion resistant by applying a barriermaterial to one or more selective regions of the implant, by renderingselective abrasive regions of the implant less abrasive, and by othersuitable arrangements as would be apparent to one of skill in the art.For example, an erosion resistant region may be smoother, softer,broader, and/or more deformable than other portions of the implant. Theprosthesis may include an erosion resistant barrier arranged to isolatethe esophagus and/or abdominal viscera from selected portions of theimplant.

The shapes, sizes and locations of the various barriers may be selectedto achieve any desired adhesion and/or erosion resistant characteristicsfor the prosthesis as would be apparent to one of skill in the art.

The erosion resistant and adhesion resistant barriers are each directedto improving particular disadvantages in the prior art. However, actualmaterials and/or barrier configurations which may be used to reduceerosion into surrounding tissue and organs may also have adhesionresistant characteristics, such as limited porosity for resistance totissue infiltration. Thus, any barrier region may be erosion resistant,adhesion resistant, or both erosion and adhesion resistant.

In one illustrative embodiment shown in FIGS. 4–7, the prosthesis 21includes a body of biocompatible repair fabric. The body includes firstand second surfaces 26, 28 with a body edge 24 extending from the firstsurface 26 to the second surface 28. The first surface is adapted toface the defect and the second surface is adapted to face away from thedefect. The body edge 24 is configured to inhibit erosion of adjacenttissue or organs due to contact with the prosthesis.

In the illustrative embodiment, the body of repair fabric includes firstand second layers of material that are attached to each other in amanner to form an erosion resistant edge. As shown in FIG. 7, the firstlayer 22 is placed over and attached to the second layer 23 along atleast one seam 47 with the second surface 28 of the second layer 23initially facing the first surface 26 of the first layer 22. The layers22, 23 may be attached proximate the outer periphery 31 of each layerusing any suitable method apparent to one of skill in the art. In oneembodiment, the layers are stitched to each other along a seam 47located inward of the peripheral edges of the layers to create anextension or seam allowance 604 at the outer periphery of the implant21.

Once attached to each other, the layers are inverted, or pulledright-side-out, such that the first surface 26 of the first layer 22 andthe second surface 28 of the second layer 23 face outwardly away fromeach other to form the first and second surfaces 26, 28 of theprosthesis. The second surface of the first layer 22 then faces thefirst surface of the second layer 23 with a cavity 606 formedtherebetween.

Inverting the fabric layers 22, 23 in this manner is facilitated with apull-through opening 600 created by maintaining a gap 602 in the seam 47at the outer periphery of the layer of fabric. In one embodiment, thegap is 1.5 to 2 inches in length for a prosthesis having a width ofapproximately 10 cm. However, those skilled in the art will recognizethat other gap lengths may be appropriate for different sizes of theprosthetic repair fabric, different attachment methods, different fabricflexibilities, and different placement of the gap along the outerperiphery 31 of the layer of fabric. In another embodiment, the gap 602may be provided in the fabric itself, such as a slit formed in one ofthe fabric layers 22, 23. It is to be understood that any suitablearrangement may be implemented to facilitate forming a prosthesis inthis manner.

As shown in FIG. 6, once the implant is inverted right-side-out, theseam allowance and peripheral edges of each layer are located inside thecavity 606 of the prosthesis, sandwiched between the two fabric layers22, 23. In this manner, the seam 47 and fabric edges are isolated fromthe adjacent tissue and organs. The outer periphery 32 of the prostheticrepair fabric 21 is configured with a flat seam edge 24 that provides arelatively broad surface area to face adjacent tissue or organs forenhanced erosion resistance. The gap may be sealed, if desired, withattachment methods, such as stitching, after inversion of theprosthesis.

In the illustrative embodiment, the first layer 22 of fabric includes alayer of tissue infiltratable fabric and the second layer 23 of fabricincludes a barrier material that is resistant to adhesions withsurrounding tissue and organs. In this regard, the second layer 23 offabric is a surface barrier 118 that reduces the incidence of adhesionswith the cavity viscera and the second surface of the layer of fabric22.

It may be desirable to provide the surface barrier 118 with some amountof slack so that the barrier does not necessarily lie directly againstthe second surface of the fabric 22. In this manner, the surface barrieris not tautly drawn against the surface of the fabric, thereby allowingslight billowing of the barrier, which may enhance the tissue ingrowthof the prosthesis. In one embodiment, the portion of the surface barrier118 provided within the body portion is configured to billow slightlyrelative to the fabric.

In some arrangements, it may be desirable to control, if not essentiallyeliminate, the amount of billowing between the surface barrier 118 andthe fabric layer 22. As shown in FIGS. 4–5, the separation between thesurface barrier 188 and the layer of fabric 22 may be controlled with acontinuous line of stitches 49 that follows the first and second sidesof the body portion to limit the cavity space within the body of theprosthesis. It is to be appreciated that any suitable arrangement ofintermittent attachment points, if even desired, may be selected toachieve any desired billowing characteristic as would be apparent to oneof skill in the art.

Since the implant is inverted right-side-out after stitching the layersof fabric, the seam allowance and peripheral edges of each layer arelocated inside the cavity 606 of the prosthesis, sandwiched between thetwo layers of fabric. The gap may be sealed with attachment methodsknown in the art, such as stitching, after inversion of the prosthesis.In this regard, the seam allowance edge is isolated from the adjacenttissue and organs, and the outer periphery 32 of the prosthetic repairfabric 21 provides a flat seam edge 24. The flat seam edge of theimplant 21 then provides a broader surface area facing any adjacenttissue or organs than the outer periphery 31 of the edges of the twolayers of material.

In the illustrative embodiment, erosion resistance of the prosthesis isfurther enhanced by the cavity space 606 internal to the prosthesis 21,which acts to bumper or pillow contact with the esophagus. Moreover,folding the fabric layer around the internal seam allowance may increasethe resilience or spring-like action of the prosthesis materials at theedge 24 to create a bumper or pillow effect for adjacent tissue ororgans which may contact the erosion resistant edge after the prosthesis21 is implanted in the patient.

To further protect the esophagus from erosion and adhesion with theprosthesis, an edge barrier 608 is formed from a material resistant toadhesions with tissue and organs. The barrier 608 is disposed on aportion of the margin of the first surface of the layer of fabricproximate the periphery of the prosthesis. The barrier 608 then createsa smooth roll over of adhesion resistant barrier around the edge 24 ofthe prosthesis towards the surface barrier 118. In this regard, theouter edge 32 of the prosthesis 21 is rendered adhesion and erosionresistant with the barriers 118, 608 at the flat seam.

In the illustrative embodiment, the edge barrier 608 extends around theouter periphery of each tail and is formed from a partial annular diskshaped to follow the contour of each tail. The barrier 608 may beextended or truncated around the periphery of the prosthesis as desiredto inhibit adhesion between the layer of fabric and the surroundingtissue and organs, including the esophagus.

To maintain the edge barrier 608 in place around the edge 24 and the topmargin of the layer of fabric, the barrier 608 may be sandwiched betweenthe first surface of the fabric 22 and the second surface of the barrier118 before attachment of the fabric to the barrier 118 at the outerperiphery 31. In this regard, the inner peripheral edge 610 extends overthe margin of the first surface of the layer of fabric and the outercircumference of the barrier 608 is symmetric to the outer periphery 31of the layer of fabric 22 and the surface barrier 118. The fabric 22,the edge barrier 608, and the surface barrier 118 are then attached,preferably with stitching proximate the periphery 31, as discussedabove, maintaining the pull-through opening 600 with the gap 602 in thestitching.

As shown in the illustrative embodiment of FIGS. 4–7, the innerperipheral edge 610 of the edge barrier 608 remains unattached and liesagainst the first surface of the fabric 22. The edge barrier 608 isstretched across the edge and over a portion of the first surface of thelayer of fabric 22. This arrangement creates some tension in the barrier608 that maintains the barrier in place around the outer margin of theperipheral edge 32. In this regard, the inner edge 610 of the edgebarrier 608 remains unattached to the fabric and allows fluid flowbetween the barrier 608 and the fabric layer 22 to reduce the incidenceof potential pockets of trapped visceral fluids.

To ensure placement of the barrier 608 against the first surface 26 ofthe layer of fabric 22, the inner peripheral edge 610 may bepre-attached to the layer of fabric 22 before the outer peripheralstitching attaches the edge-barrier, the fabric, and the surfacebarrier. Alternatively, the inner peripheral edge 610 may be attached tothe fabric layer after the prosthesis 21 is inverted right-side-out withmethods known in the art including, but not limited to, stitching,melding, and adhesives. Attachment of the inner circumference of thebarrier 608 may also attach the second layer 23 to the first layer 22 tomaintain minimal spacing or control draping of the second layer 23.

In one illustrative embodiment, the implant 21 of FIGS. 4–7 includes afabric layer 22 formed of PTFE mesh, a barrier layer 118 formed ofePTFE, and an edge barrier formed of ePTFE. It is to be appreciated thatany suitable materials may be employed to form the prosthesis as wouldbe apparent to one of skill in the art.

FIGS. 8–10 illustrate one embodiment of a manufacturing process forfabricating the prosthesis of FIGS. 4–7. As shown in FIG. 8, arectangular sheet of PTFE mesh is clamped to a frame 720 with pins 722.The first surface 26 of the mesh fabric faces up from the frame. Asshown in FIG. 9, a sheet 608 of ePTFE is then clamped in the frame overthe mesh fabric 22. As shown, the sheet of ePTFE 608 is pre-shaped toform the inner circumference 610 of the edge barrier 608. As shown inFIG. 10, a second sheet 118 of ePTFE is then clamped to the frame on topof the ePTFE barrier 608 with the second surface 28 of the barrier 118facing down.

Once clamped in the frame 720, the layers are attached to each otherwith a stitch line 47 using approximately 4 mm to 6 mm long stitchesformed of a polypropylene or PTFE monofilament. As illustrated in FIG.10, the stitch line 47 follows the desired contour for the peripheraledge 32 of the prosthesis 27, leaving a gap 602 in the stitching havinga length of approximately 1.5 inches. The stitch line 47 is placedapproximately 5 mm outside the inner circumference 610 of the barrier608. The prosthesis is then removed from the frame 720 by cutting thelayers approximately 3 mm outside the stitch line 47, forming a seamallowance.

After removal from the frame, the barrier 608 forms an annular ringaround each tail of the prosthesis having a width of approximately 8 mm,of which 3 mm is outside the stitch line forming the seam allowance andapproximately 5 mm overlies the first surface of the fabric layerforming the margin barrier 116. The prosthesis 20 is then invertedthrough the gap 602, placing the second side of the barrier layer 118,the first side of the layer of fabric, and the inner circumference 610of the edge barrier 608 external to the cavity 606, as shown in FIGS. 4and 6. The gap may then be stitched closed with stitches external to thecavity 606.

After inversion of the prosthesis, in the illustrative embodiment, thebase of the body of the prosthesis is approximately 4 inches long, andthe first and second sides are each 3.5 inches long. The vertex of theprosthesis has a radius of curvature of approximately 0.19 inches. Eachtail 142, 144, extends approximately 1.0 inch from the base of the bodyof the prosthesis and have a radius of curvature of approximately 0.81inches. The opening limited by the base of the body and each tail has aradius of curvature of approximately 0.75 inches.

Separation of the surface barrier 118 from the fabric layer 22 may belimited with a continuous line of stitches 49 through the body 134 ofthe prosthesis. In the illustrative embodiment, the stitches 49 followthe slope of the first and second sides and form a V-shaped stitch linein the body of the prosthesis. Each side of the stitch line isapproximately 2.25 inches long and is spaced from the outer periphery 32of the prosthesis by approximately 0.83 inches

Additional or alternative erosion resistant barriers may be provided toinhibit erosion and adhesion of the prosthesis into the surroundingtissue and organs. When the tissue or organ, such as the esophagus orother tube-like structure applies a force within the plane of theprosthesis, e.g., normal to an edge of the layer of fabric, it may bedesirable to inhibit the tube-like structure from directly contactingthe peripheral edge 32 of the prosthesis.

In the illustrative embodiment, the prosthesis has an opening 30 locatedbetween the two tails 142, 144 with a bottom edge 726 of the openingdefined by the base 136 of the body portion. To isolate or buffer theesophagus or other tube-like structure from contact with the edge of theopening, the prosthesis includes a tongue-like edge barrier 724 thatextends out over the opening and between the two tails 142, 144. Asshown in FIGS. 4–5, the outer periphery 728 of the tongue intersects theouter periphery of each tail 142, 144 at first and second support points730, 732 respectively. The tongue is attached to each tail at first andsecond attachment points 734, 736 located on opposing sides of theopening. Each attachment point is located between the bottom edge of theopening and the outer end or apex 750, 752 of each tail. As shown, theattachment points are located between the bottom edge 726 of the openingand the support points 730, 732, respectively.

The tongue 724 is configured to extend away from the base and over theopening 30. In one embodiment, the tongue is formed from a flexible ordeformable material that acts to cushion the esophagus 202 within theopening. The tongue is configured to fold into the opening and over theopening edge of the fabric toward the second surface 28 when subjectedto a force applied by the esophagus.

As shown in FIGS. 4 and 11–12, an outer portion of the tongue isconfigured to fold along a first fold line 754 that extends between thesupport points 730, 732. As shown, the first fold line 754 is spacedfrom the bottom edge 726 of the opening by a portion of the tongue thatforms a ledge 760 over the opening. In this manner, the tongue ledgebuffers the esophagus from the opening edge of the fabric layer.

As the force F against the tongue increases, the tongue will fold andcollapse further into the opening along a fold line that shifts towardthe base of the opening, reducing the length of the ledge 760 overlyingthe opening. As shown in FIGS. 13–14, the tongue may continue tocollapse into the opening until it reaches a second fold line 756 thatextends between the first and second attachment points 734, 736 whichare located at a distance from the bottom of the opening so as tomaintain a ledge 760 over the opening. In this manner, the fold line mayextend from a region of the first tail 142 extending from the firstsupport point 730 to the first attachment point 734 to a second regionof the second tail 144 extending from the second support point 732 tothe second attachment point 736.

Once the tongue folds and collapses into the opening along the secondfold line 756, any additional force against the tongue will betransmitted to the tails 142, 144 through the first and secondattachment points 734, 736. In this manner, the tails 142, 144 and thebody of the prosthesis act together to resist collapse of the tongueinto the opening so as to maintain the ledge 760 between the second foldline 756 and the bottom edge 726 of the opening to buffer the esophagusfrom contacting the bottom on the opening.

To enhance the erosion resistance of the prosthesis along the opening,the tongue may be formed from a material that is smoother, softer, andmore deformable than the body of the prosthesis, as discussed above. Theerosion resistance of the tongue may also be enhanced by presenting abroad surface area to the esophagus. In this regard, the tongue may beconfigured to fold over the opening edge with a relatively large radiusof curvature. The tongue may be formed from a material that provides aresilience or spring-like action to further buffer the esophagus as thetongue folds over the opening.

The tongue may also be rendered adhesion resistant to limit theincidence of adhesion between the tongue and the esophagus. In oneembodiment, the tongue is formed from a layer of adhesion resistantmaterial. In this manner, the tongue may be used in conjunction with theopening edge barrier to further ensure the erosion and adhesionresistance of the prosthesis.

In the illustrative embodiment, the tongue is configured with agenerally tear drop shape that is suitable for attachment to theprosthesis at the periphery of the opening. The sides 738, 740 of thetongue converge at a vertex 742 which overlaps the margin of the body ofthe prosthesis at the bottom edge of the opening. The sides of thetongue overlap and follow the sides of the tails as the tongue extendsoutwardly away from the bottom edge of the opening. The tongue includesa broad curved outer edge 744 for facing the esophagus when theprosthesis is implanted in the abdominal cavity of the patient. Thecurved edge 744 is configured to intersect the outer periphery of theprosthesis at the support points 730, 732.

The outer edge 744 of the tongue may be configured to have a widthgreater than the width of the adjacent tube-like structure. For anesophagus that is 4 cm, the tongue may have a width greater than 1.5inches. However, to limit the impact the tongue may have on tissueingrowth to the body and tails of the prosthesis, the tongue may have awidth less than 2.5 inches. Thus, the tongue may be configured with awidth in the range of approximately 1.5 to approximately 2.5 inches.

To maintain an essentially planar extension of the tongue 724 in anunstressed state, the length and width of the tongue and attachmentpoints 734, 736 may be selected to limit drooping or sagging of thetongue from its own weight. In one embodiment, the tongue has a maximumlength of approximately 2 inches and a width of approximately 2 inches.Of course, any suitably sized tongue may be employed with the prosthesisas would be apparent to one of skill.

The tongue-like edge barrier may be attached to the layer of fabricusing any suitable attachment methods. As noted above, the attachmentpoints 736, 734 maintain a portion of the tongue across the opening toinhibit the esophagus from contacting the edge of the fabric at theopening. In one embodiment, the tongue is attached to the body of theprosthesis with intermittent stitches 746 spaced approximately ¼ inchinward from the periphery of the tongue. A first group of stitchesattaches the first side of the tongue to the first tail 142 to createthe first attachment point 736 slightly indented from the peripheraledge of the fabric. A second group of stitches attaches the second sideof the tongue to the second tail 144 to create the second attachmentpoint 736, also slightly indented from the peripheral edge of thefabric. A third group of stitches attaches the vertex 742 of the tongueto the margin of the layer of fabric proximate the bottom edge of theopening. Those skilled in the art will recognize that alternativeattachment methods and positions may be appropriate to attach the tongueso as to extend over the opening and extend between the tails of theprosthesis. For example, the attachment points 734, 736 may be locatedcoincident with the support points 730, 732 between the tongue and eachtail.

In certain circumstances, it may be desirable to employ a tongue-likeedge barrier having a different shape and/or size to provide differingfold lines, tongue flexibility, and/or protection areas. Several otherillustrative embodiments of a tongue is shown in FIGS. 15–16.

As shown in FIG. 15, the prosthesis 25 may include a tongue-like edgebarrier 724 with a reverse tear drop shape. As shown, the vertex of thetear drop shape is placed towards the esophagus and the broad edge 744is placed over the margin of the fabric proximate the bottom edge of theopening. In this regard, the support points 730, 732 and the attachmentpoints 734, 736 are shifted back towards the bottom edge of the opening.In this manner, the fold lines are also shifted back towards theopening, thereby decreasing the buffer zone created by the ledge 760between the bottom of the opening and the esophagus. Since the supportpoints between the periphery of the prosthesis and the tongue areshifted back, additional portions of the peripheral edge of the fabricmay be covered with erosion and/or adhesion resistant edge barriers, asdiscussed above. As shown, the tongue overlaps a larger surface area ofthe margin of the fabric proximate the opening such that less tissueinfiltratable fabric is exposed to the surrounding tissue and viscera.

As shown in FIG. 16, the prosthesis 27 may include a tongue-like edgebarrier 724 having a generally rectangular shape. The tongue includes arounded end that extends away from the bottom edge of the opening and isplaced proximate the esophagus when the prosthesis is implanted. Similarto the reverse tear drop shape discussed above, the rectangular tongue724 is narrower than the tongue of FIGS. 4–7 at the support points 730,732. As such, the edge barrier 608 on the tails 142, 144 may be extendedalong the peripheral edge toward the opening in the fabric.

In certain repair procedures, it may be desirable to configure theprosthesis to include tails having other shapes. For example, the tailsmay be configured to reduce or avoid contact with the esophagus, toextend further over the diaphragm, and/or to completely or partiallysurround the esophagus.

In one illustrative embodiment shown in FIGS. 17–21, the prosthesis isconfigured to have a boomerang or arrowhead shape, similar inarrangement to the heart shaped implant of FIGS. 1–3. The prosthesis 29includes a triangular shaped body portion 134 that is configured tocover the defect, such as an enlarged or weakened hiatus. The prosthesisis also provided with first and second tails 142, 144 that extend awayfrom the base 136 of the body portion and essentially follow the slopeof the sides of the body portion. As shown, the width of each taildecreases in a direction from the base of the body to the outer end ofthe tail. In this manner, the tails 142, 144 are narrower than the tailsof FIGS. 1–3 to form a wider opening 30.

In the illustrative embodiment, the prosthesis includes a tissueinfiltratable fabric layer 22 and a surface barrier 118 that covers thesurface of the fabric layer that will face the abdominal viscera. Anedge barrier 114 and a margin barrier 116 are also provided on theprosthesis, similar to those discussed above with respect to FIGS. 1–3.One or more regions of the opening edge between the tails may beconfigured to be erosion and/or adhesion resistant to limit theincidence of postoperative erosion and/or adhesion of selective portionsof the fabric into the surrounding tissue and organs, such as theesophagus.

In the illustrative embodiment shown in FIGS. 17–21 the prosthesisincludes an erosion resistant edge barrier 120 that extends around theedges of the tails surrounding the opening 30 to isolate and buffer theopening edge 54 of the fabric 22 from adjacent tissue or organs, such asthe esophagus. The edge barrier 120 extends from the first surface 26 ofthe body portion, over the fabric edge 22, and then back toward thesecond surface 28 of the body. In this manner, the fabric edge 54, whichextends between the first and second surfaces of the fabric along theopening 30, is covered by the erosion resistant edge barrier 114 so thatthe portion of the esophagus passing adjacent the edge is isolated fromand does not directly contact the fabric edge. This arrangement alsoforms a margin barrier 122 to isolate and buffer the esophagus fromportions of the margin of the fabric 22.

As shown, portions of the barrier 120 may extend beyond the fabric edgeto form a first extension 700 and second extension 702 that projectbeyond the edge of the fabric. In one embodiment, the barrier 120 isformed from a material that is more deformable than the fabric edge sothat the barrier 120 may deform or move relative to the fabric edge tobuffer the esophagus from abrasions by the edge of the fabric.

In the illustrative embodiment, the erosion resistant edge barrier 120includes an inner surface 502 that is spaced from the fabric edge 54 bya distance D in a direction that is approximately normal to the fabricedge. This arrangement forms a gap or pocket 500 between the inner faceof the edge barrier and the fabric edge. The pocket 500 forms a cushionspace that provides a bumper effect or spring-like action to pillow orotherwise cushion the esophagus from the implant.

FIGS. 20–21 schematically illustrate several examples of the cushioningeffect of the erosion resistant edge 120 of the prosthesis when engagedby adjacent tissue or organs. It is to be appreciated, however, that theprosthesis may employ any suitable arrangement for providing an erosionresistant edge.

As shown in FIG. 20, the edge barrier 120 and the pocket 500 maycompress toward the fabric edge to cushion or bumper the esophagus 202in response to a force F between the esophagus and the implant in adirection generally perpendicular to the fabric edge 54. In this manner,the first and second extensions 700, 702 of the edge barrier may alsobow away from each other to present a larger surface area to theesophagus to enhance force distribution between the edge and theesophagus for added erosion resistance.

Rather than being compressed, the edge barrier 120 may bend relative tothe fabric edge, as shown in FIG. 21, when engaged by the esophagus 202.In this manner, the edge barrier forms a ledge 704 having a broadsurface area, as compared to the fabric edge, that may distributeabrasive forces between the implant and the esophagus over a largersurface area to reduce potential erosion. The construction or materialof the edge barrier 120 may also provide a resilient or spring-likeaction, such that the ledge may buffer and cushion the esophagus fromthe fabric edge 54 and then return to an essentially planar positionwhen not engaged by the esophagus.

As is to be appreciated, it may be desirable to configure the edgebarrier 120 so as to bend and flex relative to the fabric edge in amanner that provides a desired amount of erosion resistance. Variousfactors may effect the particular configuration of the edge barrier,including the stiffness of the fabric, the stiffness of the barriermaterial, the resiliency of the barrier material, and the weight of thebarrier material. For example, the distance between the inner surface ofthe edge barrier 120 and the fabric edge 54 may be as large as 3.0 mm.In one embodiment, for a repair fabric formed of polypropylene mesh andan edge barrier formed of ePTFE, the distance ranges from approximately1.0 mm to approximately 2.5 mm. In another embodiment, for a repairfabric made of PTFE mesh which is more flexible than polypropylene, thedistance is less than approximately 1.5 mm. Of course, the spacingbetween the inner surface of the edge barrier and the fabric edge mayvary as would be apparent to one of skill in the art to provide anydesirable level of erosion resistance.

As noted above, the barrier 120 may also provide adhesion resistantcharacteristics to reduce adhesions between the edge barrier 120 and theesophagus. A marginal portion of the first surface 26 (defect facing) ofthe fabric surrounding the edge is isolated by the margin barrier 122.Similarly, a margin portion of the second surface of the fabricsurrounding the edge is isolated by the surface barrier 118. The marginbarriers limit the prospect of adhesions between the segment of theesophagus extending adjacent the edge and the marginal portions of thefabric proximate the edge.

In the illustrative embodiment of FIGS. 17–21, the opening marginbarrier 122 includes a partial annular ring of barrier material thatoverlies the first surface 26 of the fabric 22 at the marginal portionsurrounding the opening 30. As shown, the first extension 700 of themargin barrier extends beyond the opening edge 54 of the fabric.Similarly, the second extension 702 of the surface barrier 118 extendsbeyond the opening edge of the fabric so as to lie adjacent the marginbarrier. The margin barrier 122 is attached directly to the surfacebarrier 118, without the intervening layer of fabric therebetween, toform the erosion resistant edge barrier 120 which isolates and buffersthe opening edge of the fabric from the esophagus. The attachment at theouter edge of the margin barrier 122 and the surface barrier 118 formsthe inner surface 502 of the edge barrier that is spaced from the edge54 of the fabric by the pocket 500. As is to be appreciated, thisconfiguration also renders the edge barrier 120 adhesion resistant.

The prosthesis 20 may employ an erosion resistant edge formed using anysuitable arrangement apparent to one of skill in the art. In anotherillustrative embodiment shown in FIG. 22, the erosion resistant edgebarrier 120 includes a separate, continuous barrier cuff 706 that isloosely wrapped about the opening edge 54 of the fabric. In this regard,the cuff extends continuously from the opening margin 55 on the firstsurface of the fabric, across the opening edge 54, and onto a portion ofthe surface barrier 118 adjacent the opening edge. Thus, the cuff isconfigured to provide the margin barrier 122 on the first surface of thefabric, and the erosion resistant edge barrier 120 for isolating andbuffering the opening edge. Similar to the embodiment described above,the loose wrapping of the barrier cuff forms a gap or pocket 500 thatspaces the inner surface 502 of the cuff from the opening edge of thefabric to buffer or cushion the esophagus or other cord-like structurefrom the fabric edge. It is to be understood that this embodiment mayalso render the edge-adhesion resistant.

In the illustrative embodiment shown in FIGS. 17–21, the opening edgebarrier 120, the opening margin barrier 122 and the surface barrier 118are stitched to the fabric 22 with a series of continuous connectingstitches. As shown, a pair of stitch lines 45, 46 attach the annularbarrier layer 122 and a portion of the surface barrier 118 to the fabric22 to form the edge barrier 120. The first line of stitches 45 attachesthe extension portions 700, 702 of the barrier layers 122, 118 directlyto each other to form the opening edge barrier 120 which isolates andbuffers the opening edge 54 of the fabric 22 from the esophagus. Thesecond line of stitches 46 attaches the outer circumference 52 of theopening margin barrier 122 and corresponding region of the surfacebarrier 118 to the fabric 22. A third stitch line 47 attaches the outerperimeter of the surface barrier 118 to the fabric along the outerperiphery 32 of the implant. One or more attachment points (not shown)between the layer of fabric 22 and the surface barrier 118 may beprovided to limit or control the spacing or drape between the layers.

In an exemplary embodiment shown in FIGS. 17–21, the body of theprosthesis forms an equilateral triangle with the base and each side ofthe triangle being approximately 2.125 inches long. Each tail 142, 144,extends approximately 1.125 inches beyond the base of the body. Thewidth of each tail at the base of the body is approximately 1 inch andthe width of each tail at its peak or end 750,752 is approximately 0.375inch. The surface barrier 118 is generally symmetric to the layer offabric at the outer periphery 32 of the prosthesis.

The annular shaped barrier layer 122 is approximately 1 cm wide andfollows the curvature of the opening between the two tails 142, 144.Approximately 0.5 cm of the barrier 122 overlies the mesh fabric 22proximate the fabric opening 30 and approximately 0.5 cm extends beyondthe edge 54 of the layer of fabric, forming the upper surface 700 of thebarrier 120. The edge of the surface barrier at the opening also extendsbeyond the opening edge 54 of the layer of fabric and is symmetric tothe outer circumference of the barrier 122. Accordingly, the extensionof the surface barrier 118 forms the lower surface 702 of the barrier120. Alternative embodiments may extend the surfaces 700, 702 up toapproximately 1.5 cm from the edge 54 of the opening in the fabric.

The outer edge and margin barriers 114, 116 are situated along the edgesand margins of the outer periphery 32 of the mesh fabric 22 and formedby heat melding the mesh fabric 22 to close the interstices or openingsin the mesh fabric 22. The outer margin barrier 122 has a width ofapproximately 1/16 to ⅜ inch. It should be understood, however, thatthese dimensions are merely exemplary and that any suitable sizes andshapes may be employed for the prosthesis 20.

In some instances, an erosion resistant edge may be obtained by foldinga layer of repair fabric onto itself to form a rounded edge whichprovides a cushioning effect along the folded portion of the prosthesis.In one illustrative embodiment shown in FIGS. 23–25, a prosthesis 33 isformed from a layer of repair fabric 22 having a kite-shaped ordiamond-shaped configuration (FIG. 23) that is folded onto itself toproduce a triangular-shaped body 800 (FIG. 24). The body is formed byfolding a first corner 810 of the fabric across the layer of fabric, asindicated by arrow A, toward the opposing second corner 814 of thefabric. As shown, the first corner is positioned proximate to the secondcorner so that an erosion resistant edge 24 is formed across the layerof fabric generally between the opposing third and fourth corners 812,816. As shown in FIG. 25, the edge 24 provides a relatively broadsurface area to face adjacent tissue or organs for enhanced erosionresistance.

The folded shape of the prosthesis may be maintained by the tension inthe prosthesis fold, peripheral attachment of the prosthesis to thetissue at the defect site, and/or pressure from surrounding tissue andorgans. If desired, the first corner 810 may be attached to the fabriclayer 22 using any suitable method apparent to one of skill in the art.For example, the corner may be stitched down to the fabric layer.

The prosthesis may formed from a layer of tissue infiltratable materialthat allows tissue ingrowth. In one embodiment, the prosthesis is formedfrom PTFE mesh, although any suitable material may be employed as wouldbe apparent to one of skill in the art. The prosthesis may include oneor more barriers configured to inhibit adhesions with and/or erosioninto adjacent tissue and organs, such as the esophagus or othercord-like structure. As described above, the repair fabric may includean edge barrier about a portion of or the entire outer peripheral edgeof the fabric and/or a surface barrier that is arranged on one or moreregions of a surface of the fabric layer. As is to be understood, anysuitable barrier arrangement may be employed as would be apparent to oneof skill in the art.

The prosthesis may be particularly suitable for repairing a hiatalhernia since a triangular-shaped body generally conforms to the shape ofthe crura. The folded edge may be positioned toward the esophagus toprovide a cushion or bumper arrangement that reduces the incidence oferosion into the esophagus. It is to be appreciated, however, that theprosthesis may be formed by folding a layer of fabric into any desiredconfiguration for a particular application that may benefit fromenhanced erosion resistance provided by the folded edge.

It is to be understood that various suitable stitch patterns may beimplemented with any of the illustrated prostheses described above forconnecting one or more of the barriers to the fabric 22. Examples ofother stitch patterns include, but are not limited to, a plurality ofintermittent stitches between the barrier and the fabric, or a singleline of continuous stitches that follow the contour of the periphery 32and form a concentric, spiral pattern from the outer periphery 32 to thecenter of the prosthesis. It may be desirable in certain cases to limitthe amount and/or location of stitching to avoid sealed pockets withinthe prosthesis. Intermittent stitches or gaps in continuous stitches mayencourage fluid flow into and out of volumes delimited by the layers offabric and/or barrier materials. It also may be desirable to limit theamount of stitching to maintain the flexibility of the prosthesis.Appropriate biocompatible thread materials may be used for Joining thebarrier and tissue infiltratable materials together, as would beapparent to one of skill in the art. For example, the stitches mayinclude, but are not limited to, polypropylene monofilament or ePTFEyarn.

Rather than stitching the barrier materials to the fabric, otherattachment methods may be employed as would be apparent to one of skillin the art. For example, the barrier and the fabric may be attachedusing any suitable tacking, stapling, heat bonding, chemical bonding andmolding techniques.

Although several embodiments of barriers have been described, it is tobe understood that the prosthesis may employ one or more barriers of anysuitable configuration as would be apparent to one of skill in the art.For example, any one or combination of erosion resistant and/or adhesionresistant barriers may be formed by altering or treating the fabric soas to occlude tissue ingrowth, by covering the fabric with a barriermaterial, or any combination of fabric treatment and barrier materials.Additionally, any one or more of the barrier structures may be formed byboth treating the fabric layer and covering the treated fabric with abarrier layer.

The prosthesis may be provided with one or more erosion resistant and/oradhesion resistant barriers that are pre-attached to the fabric and/orother barriers. Alternatively, the prosthesis may be provided as a kitof separate parts with the barriers either being attached to the fabricand/or other barriers during the repair procedure or simply overlaid ona desired portion of the fabric 22 to be held in place by adjacenttissue and/or organs.

In one embodiment, the tissue infiltratable layer 22 is formed of asheet of biologically compatible, flexible, prosthetic repair fabrichaving a plurality of interstices or openings which allow tissueingrowth, integrating the repair device to host tissue afterimplantation. The suture pull-out strength of the tissue infiltratablelayer and/or the barrier portions should be sufficient to support theunderlying anatomical weakness and withstand the dynamic environment ofthe implant area. In the case of hiatal hernia repair, the meshpreferably has a suture pull-out strength of approximately 2 pounds persquare inch and is sufficiently flexible to accommodate the dynamicenvironment and esophagus during respiration, coughing, and swallowing.A representative material is knitted polypropylene monofilament mesh,such as BARD MESH, available from C. R. Bard, Inc. When implanted, thepolypropylene mesh promotes rapid tissue ingrowth into and around themesh structure. Alternatively, other surgical materials which aresuitable for tissue reinforcement in defect closure may be utilizedincluding, without limitation, polytetrafluoroethylene (PTFE) mesh,PROLENE, SOFT TISSUE PATCH (microporous ePTFE), SURGIPRO, TRELEX,ATRIUM, MERSELENE, non-absorbable collagen, and polyester. Absorbablematerials, including polyglactin (VICRYL), polyglycolic acid (DEXON),and absorbable collagen may also be employed. It is contemplated thatthe fabric may be formed from monofilament or multifilament yarns whichmay be woven, knitted, molded, or otherwise interengaged to form thetissue infiltratable component of the implant.

In one embodiment, one or more of the barriers may be formed from asheet of expanded polytetrafluoroethylene (ePTFE), such as GORE-TEXavailable from W. L. Gore & Associates, Inc., having a pore size(submicronal) that discourages tissue ingrowth and adhesion. Arepresentative and non-limiting sampling of other suitable barriermaterials includes silicone elastomer, such as SILASTIC Rx Medical GradeSheeting Platinum Cured) distributed by Dow Corning Corporation, TEFLONmesh, microporous polyproplyene sheeting (CELGARD), collagen, hyaluronicacid, carboxymethyl cellulose, and glycolic acid polymers. Autogenous,heterogeneous, and xenogenic tissue also are contemplated including, forexample, pericardium and small intestine submucosa. Absorbablematerials, such as oxidized, regenerated cellulose (INTERCEED (TC7)) maybe employed for some applications. The barrier can be a blend, mixture,or hydrogel of any of the materials to form a temporary or permanentbarrier for adhesion formation.

As indicated above, one or more of the barriers may be formed bytreating or altering a portion of the tissue infiltratable layer to forma surface that does not promote tissue ingrowth. In one embodiment, oneor more portions of the fabric layer are melted and resolidifed torender those portions of the fabric adhesion resistant. Other suitabletechniques may include ultrasonic, induction, vibration, infrared/laserwelding and the like. The fabric pores may be sealed with compatiblematerials to prohibit tissue ingrowth. It is to be appreciated that anysuitable method may be used to reduce selected portions of theprosthesis adhesion resistant as would be apparent to one of skill inthe art.

The prosthesis of tissue infiltratable fabric and barrier regions isrelatively flat and sufficiently pliable to allow a surgeon tomanipulate the shape of the implant to conform to the anatomical site ofinterest and to be sutured or stapled thereto. Preferably, theprosthesis is deliverable to the patient's cavity through a trocar or alaparoscopic cannula for skin incision. The shape and size of theprosthesis, including the fabric 22 and any of the barriers, may varyaccording to the surgical application as would be apparent to one ofskill in the art. In this regard, it is contemplated that the fabricand/or any barrier may be pre-shaped or shaped by the surgeon during thesurgical procedure.

FIG. 26 illustrates a representative application of the prosthesis inthe repair of a hiatal hernia or in the treatment of GERD. Theprosthesis 29 may be placed over the defect without approximating thetissue, effecting the repair in a substantially tension-free manner.Alternatively, the prosthesis may be employed in conjunction with acruroplasty to reinforce the stitches with tissue infiltration over asurface area and alleviate the likelihood of suture pullout when a forceis applied to the crura, that otherwise potentially could lead torecurrent herniation. It is to be understood that the prosthesis may beemployed in any suitable manner for other procedures as would beapparent to one of skill.

It should be understood that the foregoing description of variousembodiments of the invention are intended merely to be illustrativethereof and that other embodiments, modifications, and equivalents ofthe invention are within the scope of the invention recited in theclaims appended hereto.

1. An implantable prosthesis for repairing a tissue or muscle walldefect in the vicinity of an esophagus, the implantable prosthesiscomprising: a repair fabric of implantable, biologically compatiblematerial, the repair fabric having an opening that is adapted to receivethe esophagus, the repair fabric being susceptible to the formation ofadhesions with and erosion into tissue and organs and including firstand second surfaces and a fabric edge extending from the first surfaceto the second surface, the first surface adapted to face the tissue ormuscle wall defect and the second surface adapted to face away from thedefect, the repair fabric including a body portion and first and secondtails extending away from the body portion, the body portion beingconfigured in a generally triangular shape with a base having first andsecond segments, the first tail extending from the first segment of thebase and the second tail extending from the second segment of the base,the opening being located along the base between the first and secondtails; and an edge barrier that is adapted to inhibit the formation ofadhesions with at least a portion of the fabric edge, the edge barrierbeing disposed on a portion of the first surface of the repair fabricproximate the opening, the edge barrier extending beyond the base tooverlie a portion of the opening between the first and second tails, theedge barrier including an outer portion that is adapted to fold into theopening along a fold line that extends across the opening from the firsttail to the second tail, the edge barrier further including a ledgeportion that overlies the opening between the fold line and the bodyportion, the edge barrier including a curved outer edge that extendsacross the opening from the first tail to the second tail, the outeredge overlying the first tail at a first support point and the secondtail at a second support point, the fold line extending from the firstsupport point to the second support point.
 2. The implantable prosthesisaccording to claim 1, wherein the repair fabric includes a plurality ofinterstices that are constructed and arranged to allow tissue ingrowth.3. The implantable prosthesis according to claim 1, wherein repairfabric is formed from one of a PTFE mesh and a polypropylene mesh. 4.The implantable prosthesis according to claim 1, wherein the repairfabric includes a first surface and a second surface, the first surfaceadapted to face the tissue or muscle wall defect and the second surfaceadapted to face away from the defect, the implantable prosthesis furthercomprising a surface barrier that inhibits the formation of adhesionswith tissue and organs, the surface barrier being disposed on at least aportion of the second surface of the repair fabric.
 5. The implantableprosthesis according to claim 4, wherein the surface barrier is disposedon substantially the entire second surface of the repair fabric.
 6. Theimplantable prosthesis according to claim 4, wherein the surface barrieris formed from ePTFE.
 7. The implantable prosthesis according to claim1, wherein the edge barrier has a tear drop-shaped configuration.
 8. Animplantable prosthesis for repairing a tissue or muscle wall defect inthe vicinity of an esophagus, the implantable prosthesis comprising: arepair fabric of implantable, biologically compatible material, therepair fabric having an opening that is adapted to receive theesophagus, the repair fabric being susceptible to the formation ofadhesions with and erosion into tissue and organs and including firstand second surfaces and a fabric edge extending from the first surfaceto the second surface, the first surface adapted to face the tissue ormuscle wall defect and the second surface adapted to face away from thedefect, the repair fabric including a body portion and first and secondtails extending away from the body portion, the body portion beingconfigured in a generally triangular shape with a base having first andsecond segments, the first tail extending from the first segment of thebase and the second tail extending from the second segment of the base,the opening being located along the base between the first and secondtails; and an edge barrier that is adapted to inhibit the formation ofadhesions with at least a portion of the fabric edge, the edge barrierbeing disposed on a portion of the first surface of the repair fabricproximate the opening, the edge barrier extending beyond the base tooverlie a portion of the opening between the first and second tails, theedge barrier including an outer portion that is adapted to fold into theopening along a fold line that extends across the opening from the firsttail to the second tail, the edge barrier further including a ledgeportion that overlies the opening between the fold line and the bodyportion, the edge barrier including a curved outer edge that extendsacross the opening from the first tail to the second tail, the outeredge overlying the first tail at a first support point and the secondtail at a second support point, the edge barrier being attached to thefirst and second tails at first and second attachments points,respectively, the first and second attachment points being locatedbetween the first and second support points and the base.
 9. Theimplantable prosthesis according to claim 8, wherein the fold lineextends from the first attachment point to the second attachment point.10. The implantable prosthesis according to claim 8, wherein the foldline extends from a region of the first tail extending from the firstsupport point to the first attachment point to a region of the secondtail extending from the second support point to the second attachmentpoint.
 11. The implantable prosthesis according to claim 1, wherein theedge barrier is disposed about at least a portion the fabric edge of oneof the first and second tails.
 12. The implantable prosthesis accordingto claim 11, wherein the edge barrier is disposed about at least aportion of the fabric edge of each of the first and second tails. 13.The implantable prosthesis according to claim 1, wherein the edgebarrier is disposed about the fabric edge of at least a portion of theopening.
 14. The implantable prosthesis according to claim 1, wherein aportion of each of the first and second tails has a rounded periphery.15. The implantable prosthesis according to claim 1, wherein each of thefirst and second tails includes an outer end that is spaced from thebase, each of the first and second tails having a width that decreasesin a direction from the base toward the outer end.
 16. The implantableprosthesis according to claim 1, wherein the repair fabric includesfirst and second layers that are joined to each other along an invertedseam that extends inwardly between the first and second layers toinhibit erosion of the tissue and organs.
 17. The implantable prosthesisaccording to claim 1, wherein the repair fabric has a heart-shapedconfiguration.
 18. An implantable prosthesis for repairing a tissue ormuscle wall defect in the vicinity of a tube-like structure, theimplantable prosthesis comprising: a repair fabric of implantable,biologically compatible material, the repair fabric having a generallyheart shaped outer periphery with a pair of rounded lobes and an openingalong a portion of the outer periphery that is adapted to receive thetube-like structure.
 19. The implantable prosthesis according to claim18, wherein the repair fabric is susceptible to the formation ofadhesions with and erosion into tissue and organs.
 20. The implantableprosthesis according to claim 19, wherein the repair fabric includes aplurality of interstices that are constructed and arranged to allowtissue ingrowth.
 21. The implantable prosthesis according to claim 19,wherein repair fabric is formed from one of a PTFE mesh and apolypropylene mesh.
 22. The implantable prosthesis according to claim19, wherein the repair fabric includes a first surface and a secondsurface, the first surface adapted to face the tissue or muscle walldefect and the second surface adapted to face away from the defect, theimplantable prosthesis further comprising a surface barrier thatinhibits the formation of adhesions with tissue and organs, the surfacebarrier being disposed on at least a portion of the second surface ofthe repair fabric.
 23. The implantable prosthesis according to claim 22,wherein the surface barrier is disposed on substantially the entiresecond surface of the repair fabric.
 24. The implantable prosthesisaccording to claim 22, wherein the surface barrier is formed from ePTFE.25. The implantable prosthesis according to claim 18, wherein the repairfabric includes first and second surfaces and a fabric edge extendingfrom the first surface to the second surface, the first surface adaptedto face the tissue or muscle wall defect and the second surface adaptedto face away from the defect, the implantable prosthesis furthercomprising an edge barrier that inhibits the formation of adhesions withat least a portion of the fabric edge.
 26. The implantable prosthesisaccording to claim 25, wherein the repair fabric includes a body portionand first and second lobes extending from the body portion with theopening being located between the first and second lobes, the edgebarrier being disposed on a portion of the first surface of the repairfabric proximate the opening, the edge barrier extending beyond the bodyportion to overlie a portion of the opening between the first and secondlobes.
 27. The implantable prosthesis according to claim 26, wherein theedge barrier includes an outer portion that is adapted to fold into theopening along a fold line that extends across the opening from the firstlobe to the second lobe, the edge barrier further including a ledgeportion that overlies the opening between the fold line and the bodyportion.
 28. The implantable prosthesis according to claim 27, whereinthe edge barrier includes a curved outer edge that extends across theopening from the first lobe to the second lobe, the outer edge overlyingthe first lobe at a first support point and the second lobe at a secondsupport point.
 29. The implantable prosthesis according to claim 28,wherein the edge barrier has a tear drop-shaped configuration.
 30. Theimplantable prosthesis according to claim 28, wherein the fold lineextends from the first support point to the second support point. 31.The implantable prosthesis according to claim 28, wherein the edgebarrier is attached to the first and second lobes at first and secondattachments points, respectively, the first and second attachment pointsbeing located between the first and second support points and the bodyportion.
 32. The implantable prosthesis according to claim 31, whereinthe fold line extends from the first attachment point to the secondattachment point.
 33. The implantable prosthesis according to claim 31,wherein the fold line extends from a region of the first lobe extendingfrom the first support point to the first attachment point to a regionof the second lobe extending from the second support point to the secondattachment point.
 34. The implantable prosthesis according to claim 25,wherein the edge barrier is disposed about at least a portion of thefabric edge of one of the first and second lobe.
 35. The implantableprosthesis according to claim 34, wherein the edge barrier is disposedabout at least a portion of the fabric edge of each of the first andsecond lobes.
 36. The implantable prosthesis according to claim 25,wherein the edge barrier is disposed about at least a portion of thefabric edge of the opening.
 37. The implantable prosthesis according toclaim 18, wherein the repair fabric includes first and second layersthat are joined to each other along an inverted seam that extendsinwardly between the first and second layers to inhibit erosion of thetissue and organs.
 38. The implantable prosthesis according to claim 18,wherein the repair fabric is constructed and arranged to be placedproximate an esophageal hiatus, the opening being adapted to receive theesophagus.
 39. A prosthetic repair fabric for repairing a tissue ormuscle wall defect in the vicinity of a tube-like structure, theprosthetic repair fabric comprising: a layer of fabric that issusceptible to the formation of adhesions with and erosion into tissueand organs, the layer of fabric having an opening adapted to receive thetube-like structure, the repair fabric including a body portion andfirst and second tails extending away from the body portion, the openingbeing located along an edge of the body between the first and secondtails; and an edge barrier that is adapted to inhibit the formation ofadhesions of tissue and organs with the edge of the body between thefirst and second tails, the edge barrier being attached to the firsttail at a first attachment point and to the second tail at a secondattachment point, the first and second attachment points being alignedwith each other across a segment of the opening, a portion of the edgebarrier overlying a portion of the opening and extending between thefirst and second attachment points, the edge barrier including an outerportion that is adapted to fold into the opening along a fold line thatextends across the opening from the first tail to the second tail, theedge barrier further including a ledge portion that overlies the openingbetween the fold line and the body portion.
 40. The implantableprosthesis according to claim 39, wherein the edge barrier includes acurved outer edge that extends across the opening from the first tail tothe second tail, the outer edge overlying the first tail at a firstsupport point and the second tail at a second support point.
 41. Theimplantable prosthesis according to claim 40, wherein the edge barrierhas a tear drop-shaped configuration.
 42. The implantable prosthesisaccording to claim 40, wherein the fold line extends from the firstsupport point to the second support point.
 43. The implantableprosthesis according to claim 40, wherein the first and secondattachment points are located between the first and second supportpoints and the body portion.
 44. The implantable prosthesis according toclaim 43, wherein the fold line extends from the first attachment pointto the second attachment point.
 45. The implantable prosthesis accordingto claim 43, wherein the fold line extends from a region of the firsttail extending from the first support point to the first attachmentpoint to a region of the second tail extending from the second supportpoint to the second attachment point.
 46. The implantable prosthesisaccording to claim 39, wherein the repair fabric is susceptible to theformation of adhesions with and erosion into tissue and organs.
 47. Theimplantable prosthesis according to claim 46, wherein the repair fabricincludes a plurality of interstices that are constructed and arranged toallow tissue ingrowth.
 48. The implantable prosthesis according to claim46, wherein repair fabric is formed from one of a PTFE mesh and apolypropylene mesh.
 49. The implantable prosthesis according to claim46, wherein the repair fabric includes a first surface and a secondsurface, the first surface adapted to face the tissue or muscle walldefect and the second surface adapted to face away from the defect, theimplantable prosthesis further comprising a surface barrier thatinhibits the formation of adhesions with tissue and organs, the surfacebarrier being disposed on at least a portion of the second surface ofthe repair fabric.
 50. The implantable prosthesis according to claim 49,wherein the surface barrier is disposed on substantially the entiresecond surface of the repair fabric.
 51. The implantable prosthesisaccording to claim 49, wherein the surface barrier is formed from ePTFE.52. The implantable prosthesis according to claim 39, wherein each ofthe first and second tails has a rounded periphery.
 53. The implantableprosthesis according to claim 39, wherein the repair fabric includesfirst and second layers that are joined to each other along an invertedseam that extends inwardly between the first and second layers toinhibit erosion of the tissue and organs.
 54. The implantable prosthesisaccording to claim 39, wherein the repair fabric is constructed andarranged to be placed proximate an esophageal hiatus, the opening beingadapted to receive the esophagus.
 55. The implantable prosthesisaccording to claim 39, wherein the repair fabric has a heart-shapedconfiguration.
 56. An implantable prosthesis for repairing a tissue ormuscle wall defect in the vicinity of a tube-like structure, theimplantable prosthesis comprising: a repair fabric of implantable,biologically compatible material, the repair fabric being susceptible tothe formation of adhesions with and erosion into tissue and organs andincluding first and second surfaces and a fabric edge extending from thefirst surface to the second surface, the first surface adapted to facethe tissue or muscle wall defect and the second surface adapted to faceaway from the defect, the repair fabric having an opening that isadapted to receive the tube-like structure, the repair fabric includinga body portion and first and second tails extending away from the bodyportion, the body portion being configured in a generally triangularshape with a base having first and second segments, the first tail has afirst outer edge that is opposite to and spaced from the first segmentof the base and the second tail has a second outer edge that is oppositeto and spaced from the second segment of the base, the opening beinglocated along the base between the first and second tails and having awidth that does not decrease as the first and second tails extend awayfrom the base to the first and second outer edges; and an edge barrierthat is adapted to inhibit the formation of adhesions with at least aportion of the fabric edge, the edge barrier being disposed on a portionof the first surface of the repair fabric proximate the opening, theedge barrier extending beyond the base to overlie a portion of theopening between the first and second tails, the edge barrier includingan outer portion that is adapted to fold into the opening along a foldline that extends across the opening from the first tail to the secondtail, the edge barrier further including a ledge portion that overliesthe opening between the fold line and the body portion.
 57. Theimplantable prosthesis according to claim 56, wherein each of the firstand second tails has a periphery with a rounded shape.
 58. Theimplantable prosthesis according to claim 56, wherein the repair fabricis symmetrical about an axis extending from the vertex to a midpoint ofthe base between the first and second tails.
 59. The implantableprosthesis according to claim 56, wherein the repair fabric includes aplurality of interstices that are constructed and arranged to allowtissue ingrowth.
 60. The implantable prosthesis according to claim 56,wherein the repair fabric is formed from one of a PTFE mesh and apolypropylene mesh.
 61. The implantable prosthesis according to claim56, wherein the repair fabric includes a first surface and a secondsurface, the first surface adapted to face the tissue or muscle walldefect and the second surface adapted to face away from the defect, theimplantable prosthesis further comprising a surface barrier thatinhibits the formation of adhesions with tissue and organs, the surfacebarrier being disposed on at least a portion of the second surface ofthe repair fabric.
 62. The implantable prosthesis according to claim 61,wherein the surface barrier is formed from ePTFE.
 63. The implantableprosthesis according to claim 56, wherein the edge barrier includes acurved outer edge that extends across the opening from the first tail tothe second tail, the outer edge overlying the first tail at a firstsupport point and the second tail at a second support point.
 64. Theimplantable prosthesis according to claim 63, wherein the edge barrieris attached to the first and second tails at first and secondattachments points, respectively, the first and second attachment pointsbeing located between the first and second support points and the base.65. The implantable prosthesis according to claim 56, wherein each ofthe first and second tails has a width that decreases in a directionfrom the base toward the first and second outer edges respectively. 66.An implantable prosthesis for repairing a tissue or muscle wall defectin the vicinity of a tube-like structure, the implantable prosthesiscomprising: a repair fabric of implantable, biologically compatiblematerial, the repair fabric including first and second layers that arejoined to each other along an inverted seam that extends inwardlybetween the first and second layers to inhibit erosion of the tissue andorgans, the repair fabric having an opening that is adapted to receivethe tube-like structure, the repair fabric including a body portion andfirst and second tails extending away from the body portion, the bodyportion being configured in a generally triangular shape with a basehaving first and second segments, the first tail has a first outer edgethat is opposite to and spaced from the first segment of the base andthe second tail has a second outer edge that is opposite to and spacedfrom the second segment of the base, the opening being located along thebase between the first and second tails and having a width that does notdecrease as the first and second tails extend away from the base to thefirst and second outer edges.
 67. The implantable prosthesis accordingto claim 56, wherein the repair fabric is constructed and arranged to beplaced proximate an esophageal hiatus, the opening being adapted toreceive the esophagus.
 68. An implantable prosthesis for repairing atissue or muscle wall defect in the vicinity of a tube-like structure,the implantable prosthesis comprising: a repair fabric of implantable,biologically compatible material, the repair fabric having an openingthat is adapted to receive the tube-like structure, the repair fabricincluding a body portion and first and second tails extending away fromthe body portion, the body portion being configured in a generallytriangular shape with a base having first and second segments, the firsttail has a first outer edge that is opposite to and spaced from a firstsegment of the base and the second tail has a second outer edge that isopposite to and spaced from a second segment of the base, the openingbeing located along the base between the first and second tails, each ofthe first and second tails having an outer periphery that extends fromthe first and second outer edges, respectively, toward the opening, theouter periphery being configured with a convex curve.
 69. Theimplantable prosthesis according to claim 68, wherein the repair fabricis symmetrical about an axis extending from a vertex of the body portionto a midpoint of the base between the first and second tails.
 70. Theimplantable prosthesis according to claim 68, wherein the repair fabricis susceptible to the formation of adhesions with and erosion intotissue and organs.
 71. The implantable prosthesis according to claim 70,wherein the repair fabric includes a plurality of interstices that areconstructed and arranged to allow tissue ingrowth.
 72. The implantableprosthesis according to claim 70, wherein the repair fabric is formedfrom one of a PTFE mesh and a polypropylene mesh.
 73. The implantableprosthesis according to claim 70, wherein the repair fabric includes afirst surface and a second surface, the first surface adapted to facethe tissue or muscle wall defect and the second surface adapted to faceaway from the defect, the implantable prosthesis further comprising asurface barrier that inhibits the formation of adhesions with tissue andorgans, the surface barrier being disposed on at least a portion of thesecond surface of the repair fabric.
 74. The implantable prosthesisaccording to claim 73, wherein the surface barrier is formed from ePTFE.75. The implantable prosthesis according to claim 70, wherein the repairfabric includes first and second surfaces and a fabric edge extendingfrom the first surface to the second surface, the first surface adaptedto face the tissue or muscle wall defect and the second surface adaptedto face away from the defect, the implantable prosthesis furthercomprising an edge barrier that is adapted to inhibit the formation ofadhesions with at least a portion of the fabric edge.
 76. Theimplantable prosthesis according to claim 75, wherein the edge barrieris disposed on a portion of the first surface of the repair fabricproximate the opening, the edge barrier extending beyond the base tooverlie a portion of the opening between the first and second tails. 77.The implantable prosthesis according to claim 76, wherein the edgebarrier includes an outer portion that is adapted to fold into theopening along a fold line that extends across the opening from the firsttail to the second tail, the edge barrier further including a ledgeportion that overlies the opening between the fold line and the bodyportion.
 78. The implantable prosthesis according to claim 68, whereineach of the first and second tails has a width that decreases in adirection from the base toward the first and second outer edgesrespectively.
 79. The implantable prosthesis according to claim 68,wherein the repair fabric includes first and second layers that arejoined to each other along an inverted seam that extends inwardlybetween the first and second layers to inhibit erosion of the tissue andorgans.
 80. The implantable prosthesis according to claim 68, whereinthe repair fabric is constructed and arranged to be placed proximate anesophageal hiatus, the opening being adapted to receive the esophagus.